BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMADA 14 PTA CATHETER

    MDR report key: 6086288 · Received November 8, 2016

    Report

    Report Number
    2024168-2016-07707
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    October 14, 2016
    Report Date
    November 8, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    UDI-DI
    08717648156052
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. VISUAL AND FUNCTIONAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED INFLATION ISSUE AND LEAK WERE CONFIRMED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT REVEALED NO OTHER SIMILAR INCIDENTS. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. BASED ON THE INFORMATION PROVIDED, THE REPORTED DIFFICULTIES APPEAR TO BE DUE TO OPERATIONAL CIRCUMSTANCES OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE ANTERIOR TIBIAL ARTERY. THERE WERE NO ISSUES NOTED DURING PREPARATION OF THE 2.5 X 20 MM ARMADA 14 BALLOON CATHETER; HOWEVER, AFTER ADVANCEMENT OF THE BALLOON CATHETER TO THE LESION, UPON ATTEMPTED INFLATION OF THE BALLOON, THE BALLOON DID NOT INFLATE AND A LEAK OF CONTRAST WAS OBSERVED COMING FROM THE SHAFT. THERE WAS NO RESISTANCE FELT DURING ADVANCEMENT OF THE BALLOON CATHETER TO THE LESION. THE DEVICE WAS REMOVED FROM THE ANATOMY AND A NEW BALLOON CATHETER WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739081 ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 6031441 08717648156052

    Patients

    Seq Age Sex Outcome Treatment
    1